Ablation catheter device and device for tissue ablation

Abstract

The present invention provides an ablation catheter device and a device for cauterizing tissue. [Solution] An exemplary embodiment of a catheter device has at least one inner catheter module having a first shaft and a first flexible outer structure fixed to the first shaft, wherein the first outer structure is configured to exhibit a folded state and an extended state. The catheter device has an outer catheter module having a second shaft and a second flexible outer structure fixed to the second shaft, wherein the second outer structure is configured to exhibit an initial state and an extended state. The second shaft is configured to receive an inner catheter module of at least one inner catheter module within the second shaft such that the second outer structure is in the initial state when the first outer structure is in the folded state, and the second outer structure is in the extended state when the first outer structure is in the extended state.

Description

TECHNICAL FIELD

[0001] The present invention relates to an ablation catheter device and a device for tissue ablation. BACKGROUND ART

[0002] In recent years, tissue treatment using pulsed electric fields has become increasingly established as a related clinical technique. However, the use of short high-voltage pulses acting on tissue and the associated high electric field strengths has already been the subject of intensive research for more than 40 years. This application method is based on the delivery of short pulses of high voltage amplitude, which generates a locally strong electric field in the range of up to several hundred volts per centimeter between the active electrode pairs, and is therefore classified as a non-thermal procedure. This electric field strength results in the formation of pores in cell membranes. Electroporation becomes irreversible when the electric field exceeds a certain threshold required for pore formation in the lipid bilayer of the cell membrane, and when the tissue is exposed to that electric field for a critical period of time. The pores remain permanently open, ultimately leading to programmed cell death (apoptosis) of the cell in question.

[0003] Pulsed field ablation has proven to be a promising therapeutic method, inter alia for the treatment of arrhythmias. For example, arrhythmias such as atrial fibrillation occur when affected regions of cardiac tissue form or conduct abnormal electrical signals. These disrupt normal heartbeats and cause asynchronous rhythms. A possible form of treatment for such arrhythmias is interventional suppression of the electrical signal transmission of interfering signals. Selective ablation of cardiac tissue by energy delivery via a catheter can create non-conductive lesions that prevent the propagation of unwanted electrical signals. In the case of a specific type of arrhythmia, atrial fibrillation, the source of the interfering electrical signals is in the pulmonary veins leading to the left atrium of the heart. Through catheter ablation (pulmonary vein isolation), the pulmonary veins are intentionally electrically isolated from the left atrium for treatment purposes.

[0004] Renal denervation is a method to suppress increased sympathetic nerve activity in order to treat cardiovascular disorders such as hypertension and chronic kidney diseases. This is performed via a minimally invasive procedure that uses a special catheter to suppress the nerves surrounding the renal artery. The catheter is inserted into the renal artery, and the nerves running along the outside are generally ablated through the vessel wall by thermal or chemical ablation.

[0005] Numerous clinical studies have already shown that combination therapy, including pulmonary vein isolation and renal sympathetic nerve ablation, leads to a reduction in the recurrence of atrial fibrillation after ablation. [Overview of the project] [Problems that the invention aims to solve]

[0006] Performing combined therapies, including pulmonary vein isolation and renal sympathetic nerve ablation, requires treating different areas of the patient's body, particularly different organs and / or blood vessels. Traditionally, separate devices have been used for this purpose. The same or similar problems exist when combining other treatment methods. Here again, it is often necessary to use different devices to combine treatment methods.

[0007] U.S. Patent No. 10016233 describes a combined treatment system for atrial fibrillation using cardiac ablation and renal sympathetic nerve ablation. Ablation is performed using conventional ablation techniques. Two additional separate catheters are required to perform cardiac ablation and renal sympathetic nerve ablation.

[0008] U.S. Patent No. 1,0517672 describes a system comprising a high-voltage generator and a balloon catheter system through which IRE pulses can be delivered. This is done in the inner wall of the renal artery, where the extraneuronal fibers are dissected and cauterized through the wall.

[0009] However, there is still a need for devices and systems that can be used flexibly in combinations of multiple treatment methods. In particular, there is a need for catheters that can be used flexibly in different treatment methods. [Means for solving the problem]

[0010] According to a first embodiment, an ablation catheter device is proposed. The ablation catheter device has at least one inner catheter module. The ablation catheter device has an outer catheter module. The at least one inner catheter module has (in each case) at least one first shaft and a first flexible outer structure fixed to the first shaft. The first flexible outer structure is configured to exhibit a folded state and an extended state. The outer catheter module has a second shaft and a second flexible outer structure fixed to the second shaft. The second flexible outer structure is configured to exhibit an initial state and an extended state. The second shaft (of the outer catheter module) is configured to receive an inner catheter module from at least one inner catheter module within the second shaft. The second shaft is configured to receive at least one inner catheter module of an inner catheter module within the second shaft such that the second flexible outer structure is in its initial state when the first flexible outer structure is in its folded state, and the second flexible outer structure is in its final state when the first flexible outer structure is in its extended state.

[0011] The initial state may also be referred to as the initial formation state, and the final state as the final formation state, because both states relate to, or can indicate, the formation of, the outer catheter module, and in particular, the second flexible outer structure of the outer catheter module. At least one inner catheter module and one outer catheter module may be of different types or may be associated with different catheter types. At least one inner catheter module and one outer catheter module may have, for example, different outer structures. One or more of the at least one inner catheter module, in particular each, may be of the same type or may be associated with the same catheter type. However, one or more of the at least one inner catheter module, in particular each, may differ from one another, for example, with respect to dimensions and / or size and / or their expanded state. There may be one or more intermediate states between the initial state and the final state. The intermediate states of the second flexible outer structure can be inferred according to the degree of expansion of the first flexible outer structure.

[0012] At least one internal catheter module may be based on or compatible with at least one internal catheter. An external catheter module may be based on or compatible with at least one external catheter. At least one external catheter module may be based on or compatible with an ablation catheter.

[0013] At least one internal catheter module can be configured as a balloon catheter module or may have a balloon catheter module. The balloon catheter module can be based on a balloon catheter or correspond to a balloon catheter. The first flexible external structure can be configured as a flexible membrane or may have a flexible membrane. In this case, the flexible membrane may, for example, take on a tubular form when folded. The flexible membrane may, for example, take on a balloon shape when expanded. The flexible membrane may take on a balloon shape or balloon form in one or more intermediate states. For example, starting from the initial state, the intermediate states may gradually take on a balloon shape up to the final state.

[0014] The internal catheter module may have a proximal end and a distal end. A first flexible external structure, particularly a flexible membrane, can be positioned between the distal and proximal ends. The external catheter module may have a proximal and distal end. A second flexible external structure can be positioned between the distal and proximal ends.

[0015] Multiple electrodes can be positioned on the outside of the second flexible outer structure. The second flexible outer structure may have multiple ribs or be formed by multiple ribs. At least one electrode can be positioned or formed on each of the multiple ribs.

[0016] The second flexible outer structure can be, for example, basket-shaped. For example, multiple ribs can extend within the basket shape or form a basket shape. For example, multiple ribs can extend from the proximal region of the outer catheter module, particularly the second shaft, to the distal region of the outer catheter module, particularly the second shaft.

[0017] The inner shaft may be positioned and configured within the second shaft to receive, in each case, one of the inner catheter modules. The dimensions of the inner shaft, in particular the internal cross-section and / or internal length of the inner shaft, may be such that one of the at least one inner catheter modules can be received within the inner shaft. For example, multiple inner catheter modules can be provided as at least one inner catheter module. In this case, in each case, one of the multiple inner catheter modules is insertable into the inner shaft of the outer catheter module. When the inserted inner catheter module, in particular its first flexible outer structure, transitions from its folded state to its extended state, the outer catheter module, in particular its second flexible outer structure, exhibits a final state, which depends on or at least substantially corresponds to the extended state. Next, when different internal catheter modules from among several internal catheter modules are introduced into the internal shaft and exhibit a different expansion state than the preceding expansion state, the external catheter module exhibits a termination state, which depends on or at least substantially matches the expansion state, and is therefore different from the preceding termination state. In this way, different termination states, particularly shape states or shapes, can be exhibited by the same ablation catheter device. Therefore, by introducing different internal catheter modules, different termination states can be realized for the external catheter module, particularly its second flexible external structure. Similarly, by introducing different internal catheter modules, different intermediate states can be realized for the external catheter module, particularly its second flexible external structure.

[0018] A distal electrode can be positioned at the distal end of the outer catheter module. A proximal electrode can be positioned at the proximal end of the outer catheter module. The distal electrode and / or proximal electrode may be annular in shape. Thus, the outer catheter module may have annular electrodes at the proximal and distal ends of the second flexible outer structure, in either case attached to or positioned on the second shaft.

[0019] According to a second embodiment, a device for cauterizing a patient's tissue is proposed. The device has an ablation catheter device according to the first embodiment. The device has a signal generator device that is connected to or connectable to the ablation catheter device. The device has a control and evaluation unit that is connected to or connectable to the ablation catheter device and / or the signal generator device.

[0020] The control and evaluation unit may be configured to perform and / or direct and / or control various measurement and / or treatment processes. For example, the control and evaluation unit may be configured to perform and / or direct and / or control tissue impedance determination and / or ablation and / or denervation measurement and / or nerve removal. The control and evaluation unit may be configured to perform, for example, tissue impedance determination and then, for example, ablation. In addition to or instead of this, the control and evaluation unit may be configured to perform denervation measurement and then, for example, nerve removal.

[0021] The signal generator device may have a first signal generator that generates a radio frequency (RF) signal and a second signal generator that generates a signal for pulsed electrocautery (PFA). The RF signal can be used for conventional thermal cautery. The signal for PFA (=PFA signal) can be used for irreversible electroporation.

[0022] The control and evaluation unit may be configured to deliver a first electrical signal into the tissue via an electrode constellation, particularly an ablation catheter device. The control and evaluation unit may be configured to send a first electrical signal into the tissue and receive a second electrical signal from the tissue via the electrode constellation, particularly an ablation catheter device. An electrode constellation can be understood as a pairwise association of electrodes. The signal generator evaluation unit can be configured to activate electrode pairs and / or electrode constellations, and / or to switch electrodes (electrode pairs) and / or electrode constellations.

[0023] The electrode group can be flexibly defined / formed / configured by one or more electrodes of the ablation catheter device, including a proximal electrode and / or a distal electrode, and / or a second flexible outer structure. Any desired electrode group can be formed depending on the application.

[0024] Depending on the application, the first electrical signal can be configured as a current signal, the second electrical signal as a voltage signal, or vice versa. For example, a control and evaluation unit can be configured to determine at least one, particularly local, tissue impedance from a current signal (= first electrical signal) delivered into the tissue and a voltage signal (= second electrical signal) received from the tissue. A control and evaluation unit can also be configured to determine a particularly local tissue impedance by at least two electrode groups / electrode pairs / (electrodes to be activated) that are selected / switched in particular (in time).

[0025] The control and evaluation unit can be configured to control / operate the first signal generator and / or the second signal generator to send signals. In this way, RF signals and / or PFA signals can be sent as needed.

[0026] The control and evaluation unit can be configured to activate the first signal generator or the second signal generator to deliver a signal, for example an RF signal, depending on at least one electrode temperature. For example, the control and evaluation unit can be configured to activate the first signal generator to deliver a signal, for example a PFA signal, when the electrode temperature is below a temperature limit value, and to activate the second signal generator to deliver a signal, for example a PFA signal, when the electrode temperature reaches or exceeds the temperature limit value.

[0027] Further features, characteristics, advantages and possible modifications will become apparent to those skilled in the art from the following description with reference to the accompanying drawings. [Brief Description of the Drawings]

[0028] [Figure 1] It is a schematic diagram of bipolar IRE pulses according to an exemplary embodiment.

[0029] [Figure 2] It is a schematic diagram of a pulse protocol having a plurality of consecutive bipolar pulses or bursts of bipolar pulses according to an exemplary embodiment.

[0030] [Figure 3] It is a schematic diagram of a pulse protocol for combined therapy of RF and pulsed field ablation, having at least one series of RF signals and at least one series of bipolar IRE pulses or bursts of bipolar IRE pulses according to an exemplary embodiment.

[0031] [Figure 4] It is a schematic diagram of the outer catheter module of the ablation catheter device in a folded configuration.

[0032] [Figure 5] It is a schematic diagram of the inner catheter module in an expanded configuration.

[0033] [Figure 6]Figure 4 shows a schematic diagram of an ablation catheter device according to an exemplary embodiment, having an outer catheter module and Figure 5 shows an inner catheter module.

[0034] [Figure 7] A schematic diagram of the internal catheter module in an expanded form is shown.

[0035] [Figure 8] This is a schematic diagram of an ablation catheter device according to an exemplary embodiment, having the outer catheter module shown in Figure 4 and the inner catheter module shown in Figure 7.

[0036] [Figure 9] Figure 4 is a schematic diagram of a folded outer catheter module, relating to a modified example of the catheter module.

[0037] [Figure 10] This is a schematic diagram of an ablation catheter device according to an exemplary embodiment, having the outer catheter module shown in Figure 9 and the inner catheter module shown in Figure 7.

[0038] [Figure 11] Figure 6 shows a schematic connection of the electrodes of the ablation catheter device for local impedance measurement.

[0039] [Figure 12] Figure 6 shows a schematic connection of electrodes for the ablation catheter device used for stimulating and measuring nerve activity.

[0040] [Figure 13] This is a flowchart of the steps involved in performing denervation. [Modes for carrying out the invention]

[0041] Irreversible electroporation (IRE) is a non-thermal technique that primarily uses only small amounts of electrical energy, and therefore raises the tissue temperature by only a few degrees Celsius. This is in stark contrast to conventional RF ablation (RF: radio frequency), where the tissue temperature rises by 20-70 degrees Celsius, destroying cells through heat treatment. In IRE, bipolar pulses, i.e., a combination of positive and negative electrical pulses, are typically used to avoid muscle contractions caused by the application of DC voltage as much as possible. These pulses can be applied between the two bipolar electrodes of a catheter, or between the catheter electrode and a surface electrode, usually attached to the patient's back.

[0042] Figure 1 is a schematic diagram of a biphasic IRE pulse according to an exemplary embodiment. It shows the voltage V of the biphasic PFA pulse 100 as a function of time t in the IRE ablation procedure. This exemplary embodiment relates to an IRE generator configured as a voltage source. Therefore, the IRE signals are described here in the form of their voltages. The biphasic IRE pulse includes a positive pulse 101 and a negative pulse 104, where the terms “positive” and “negative” refer to the independently selected polarities of the two electrodes driven for ablation and to which the biphasic pulse is applied. The amplitude of the positive pulse 101 is denoted as kV+ and lasts for a time 102. Similarly, the amplitude of the negative pulse 104 is denoted as kV- and has a temporal width 105. A delay time 103 may exist between the two pulse phases 101 and 104. Both the two temporal pulse widths 102 and 105, as well as the amplitudes kV+ and kV-, are independently configurable and therefore can be varied in the exemplary embodiment.

[0043] The bipolar pulse 100 schematically shown in Figure 1 can be generated by a signal generator. The format that determines the characteristics of the bipolar pulse 100 can be predetermined by the user. The pulse deflection kV+ and kV- values ​​of the positive pulse 101 and negative pulse 104 can be, for example, ±500kV. The third time interval 103 between the positive pulse 101 and the negative pulse 104 can be, for example, 2.5μs. The pulse width 102 of the positive pulse 101 may be different from the pulse width 105 of the negative pulse 104. The difference in pulse width is not shown in Figure 1. The generated pulses can be used as described below, with particular reference to Figures 11 and 12.

[0044] For an IRE pulse to create pores in tissue, the electric field strength E in the tissue between at least two electrode pairs, defined by the pulse, must exceed a tissue-dependent threshold Eth. For example, the threshold for cardiac cells is approximately 500 V / cm, while for bone it is 3000 V / cm. These differences in threshold electric field strengths allow for the selective application of IRE in different tissues. To achieve the desired electric field strength, the voltage applied to the electrode pair depends on the target tissue, the distance between the electrodes, and the size of the electrodes themselves. These parameters also affect the thermal energy input during ablation and thus influence the temperature peaks that may occur in the tissue to be treated. The applied voltage can reach several kilovolts, which is substantially higher than the 10-200 V voltages typical for thermal RF ablation.

[0045] The bipolar pulsed field ablation pulses (bipolar PFA pulses) for IRE include positive and negative pulses (as shown in the example in Figure 1) and are applied between two electrodes with a pulse width of 1 to 5 μs and an interval of 1 to 5 μs between the positive and negative pulses. The bipolar pulses are combined to form multiple pulse sequences, each sequence may contain 100 or more bipolar pulses with pulse intervals of 1 to 10 ms. The pulse sequences form bursts in each case, and the entire pulse packet of IRE ablation consists of 1 to 20 bursts / burst units, with a burst interval of 1 to 1000 ms for each unit. The total duration of the ablation can be up to 10 seconds.

[0046] Figure 2 is a schematic diagram of a pulse protocol having multiple bursts of two-phase pulses according to an exemplary embodiment. The pulse 100 is delivered in the form of one or more bursts or pulse packets 110 over the entire duration of the IRE procedure 113. Each burst 110 contains a defined number of N two-phase pulses 100, and these pulses are separated from each other by a time interval 111. Again, there is a delay time 112 between the delivery of each burst 110.

[0047] The pulse protocol shown in Figure 2 can form an electrical signal, which can be generated and used as described in more detail below. The electrical signal is configured as a burst signal sequence, as mentioned. Two bursts are observed, one of which is assigned reference number 110. Each burst contains at least two bipolar pulses 100. Each bipolar pulse 100 occurring in the burst signal sequence has the characteristics of the format shown in Figure 1, for example. The first number of bursts (two bursts in this example), the number of bipolar pulses, the second time interval 111, and the first time interval 112 between two consecutive bursts 110 can be determined by the user. The shown burst signal sequence continues for a duration 113 corresponding to the duration of irreversible electroporation.

[0048] Figure 3 is a schematic diagram of a treatment protocol comprising a burst of at least one biphase IRE pulse (PFA pulse) combined with at least one RF energy burst 120, according to an exemplary embodiment available herein. An example of use will be described in reference to Figure 13. The RF energy and IRE pulse are delivered in the form of one or more bursts 120 and 110 over the duration of the entire combined treatment 113. Each IRE burst contains a defined number of N bipolar pulses 100, which are spaced apart from each other by a time interval 111. The RF burst is represented by a sinusoidal signal with amplitude RF_A and duration 121. The RF burst is followed by a delay time 122. Both the duration of the RF burst and the subsequent delay time are controllable based on the instantaneously measured temperature at the ablation electrode. There is a delay time 112 between the delivery of individual IRE bursts 110. There is a delay time 123 between the delivery of an IRE burst and further delivery of an RF burst.

[0049] Figure 4 shows an embodiment of the outer catheter module 400 of a foldable ablation catheter device used for manipulation inside and outside a patient's organs / blood vessels. The catheter module 400 has an arbitrarily operable outer shaft 401 for insertion into a patient's organs / blood vessels and an inner shaft 406 for insertion of the inner catheter module of the ablation catheter device. The outer shaft 401 is divided over a defined length 407 and configured to form n ribs / splines 404_n. A defined number of m electrodes 405_m are attached to each of these ribs / splines 404_n. The proximal and distal ends of the ribs / splines 404_n are annular electrodes 402 and 403, respectively, which are fixedly connected to the outer shaft 401. All electrodes 405_m, 402 and 403 are exposed to the external environment and electrically connected via one or more electrical lines, which extend along the shaft 401 from the proximal end to the electrodes. Electrical supply lines are covered to be electrically insulated from each other and from the external environment.

[0050] Figure 5 shows an embodiment of the inner catheter module 420 of an ablation catheter device in an expanded state, which can be used to shape the outer catheter module 400 during the procedure. The inner catheter module 420 has an outer shaft 421, an inner shaft 423, and an expansion balloon membrane 422 fixed to the outer shaft 423. Expansion is performed through the inner shaft 421, which has a dedicated hole toward the balloon membrane 422.

[0051] Figure 6 shows an embodiment of an ablation catheter device 440, and in particular an embodiment of a catheter system 440 forming a coherent unit, the device 440 having the expandable balloon element of Figure 5 as an inner catheter module and the outer catheter module of Figure 4 for use during the procedure. The inner catheter module 420 is axially inserted into the inner shaft 406 of the outer catheter module 400, so that the balloon element and ribs / splines 404_n are flush with each other. By expanding the balloon membrane 422, the shape of the basket formed by the ribs / splines 404_n of the outer catheter module 400, together with the electrode 405_m attached thereto, matches the defined shape of the balloon element 422. This gives the outer catheter module 400 an effective diameter 442 and an effective length 441. These two parameters are particularly adjustable via the balloon module and are determined by the procedure to be performed and the geometric shape of the organ / blood vessel to be treated. The embodiment shown in Figure 6 is an example of renal denervation.

[0052] Figure 7 shows a further embodiment of the inner catheter module 430 of an ablation catheter device / catheter system in an expanded state, which may be used to shape the outer catheter module during the procedure. The inner catheter module 430 has an outer shaft 431, an inner shaft 433, and an expandable balloon membrane 432 fixed to the outer shaft. Expansion is performed through the inner shaft, which has a dedicated hole toward the balloon membrane 432.

[0053] Figure 8 shows a further embodiment of the ablation catheter device 450, in particular a catheter system forming a coherent unit, the device 450 having an inner catheter module 430 with an expandable balloon element as shown in Figure 7 and an outer catheter module 400 as shown in Figure 4, for use during the procedure. The inner catheter module 430 is axially inserted into the inner shaft 406 of the outer catheter module 400, so that the balloon element and ribs / splines 404_n are flush with each other. By the expansion of the balloon membrane 432, the shape of the basket formed by the ribs / splines 404_n, together with the electrode 405_m attached thereto, matches the defined shape of the balloon element. This gives the outer catheter module 400 an effective diameter 452 and an effective length 451. These two parameters are particularly adjustable via the balloon module and are determined by the procedure to be performed and the geometric shape given to the organ / blood vessel to be treated. The embodiment shown in Figure 8 is an example of pulmonary vein isolation.

[0054] Figure 9 shows a further embodiment of the outer catheter module 410 of a foldable ablation catheter device used for manipulation of the inside and outside of a patient's organs / blood vessels. The outer catheter module 410 has an arbitrarily operable outer shaft 411 for insertion into a patient's organ / vessel and an inner shaft 416 for insertion of the device's inner catheter module. The outer shaft 411 is divided over a defined length 418 and configured to form n ribs / splines 414_n. A defined number of m electrodes 415_m are attached to each of these splines 414_n. The proximal and distal ends of the ribs / splines 414_n have annular electrodes 412 and 413, respectively, which are fixedly connected to the outer shaft 411. In addition, a further electrode 417 having a non-traumatic shape is attached to the distal end of the shaft 411. All electrodes are exposed to the external environment and electrically connected via one or more electrical lines extending along the shaft from the proximal end to the electrodes. Multiple electrical supply lines are covered in such a way that they are electrically insulated from each other and from the external environment.

[0055] Figure 10 shows a further embodiment of an ablation catheter device 460, a catheter system that forms a coherent unit, particularly having an inner catheter section 470 with an expandable balloon element from Figure 7 and an outer catheter section 410 from Figure 9, for use during the procedure. The embodiment in Figure 10 is a modification of the embodiment in Figure 8, and in this embodiment it is modified compared to the embodiment shown in Figure 8 only by the use of the outer catheter section 410 corresponding to that from Figure 9, i.e., by a design having an additional tip electrode 417.

[0056] Figure 11 shows the mechanism and operation for determining the local impedance of the target tissue as an example of all embodiments of the illustrated ablation catheter apparatus. A current 471 is applied between the proximal ring electrode 402 and the distal ring electrode 403. To determine the impedance using Ohm's law, the voltage 472_m from each of the ablation electrodes 405_m of individual ribs / splines 404_n to the distal ring electrode 403 is measured. This corresponds to the total number of spline electrodes 405_m for the number of ribs / splines 404_n n, and therefore the same number of impedance metrics are obtained accordingly, allowing for highly selective determination of the characteristics of the target tissue.

[0057] Figure 12 schematically illustrates the mechanism and action for determining nerve conductivity. This is measured once as an initial value before ablation to characterize denervation, and again after the procedure. In the schematic action described herein, a distinction is made between the measurement of afferent nerves from the kidney to the central nervous system and the measurement of efferent nerves from the central nervous system to the kidney. An electrical stimulation pulse 481 is applied to the ablation electrode 408_na between a proximal electrode 408_np and a distal electrode 408_nd. In parallel, on the one hand, the resulting voltage Va from the ablation electrode to an electrode placed adjacent to it is measured to characterize afferent denervation. On the other hand, the resulting voltage Ve from the ablation electrode to an electrode placed distal to it is measured to characterize efferent denervation. Since this mechanism occurs independently in each rib / spline n, a total of the same number of efferent and afferent voltages are obtained.

[0058] Figure 13 shows a schematic sequence 500 for performing a denervation procedure. In the first step 501, the ablation catheter device is inserted into the patient via an intravascular route. Once the ablation catheter device is in place, it is confirmed whether the electrodes are in good contact with the tissue by measuring the local impedance at the ablation electrodes of multiple splines (step 502). If contact with individual electrodes is not ensured, the electrodes can be selectively turned off by the control and evaluation unit. In the next step 503, initial values ​​of afferent and efferent nerve conductivity are recorded by the mechanism described in Figure 12. Next, in step 504, it is possible to select from two types of procedures: denervation by pulsed field ablation (PFA), or a combination procedure of PFA and RF energy. In the case of PFA denervation (step 505), the procedure is performed using a two-phase IRE pulse based on an exemplary protocol as shown in Figure 2. If the combination procedure of PFA and RF (step 506) is selected, the procedure is performed based on a combination protocol as illustrated in Figure 3. Regardless of the denervation procedure selected, neural activity is subsequently recorded again to characterize the denervation (step 508) as shown in Figure 12 (step 507).

Claims

1. An internal catheter module (420, 430) having a first shaft (421, 431) and a first flexible outer structure (422, 432) fixed to the first shaft (421, 431) and configured to exhibit a folded state and an extended state, The external catheter module (400, 410) comprises a second shaft (401, 411) and a second flexible external structure fixed to the second shaft (401, 411) and configured to exhibit an initial state and an end state, Ablation catheter device (440, 450, 460) wherein the second shaft (401, 411) is configured to receive an inner catheter module (420, 430) of at least one inner catheter module (420, 430) within the second shaft (401, 411) such that the second flexible outer structure exhibits the initial state when the first flexible outer structure (422, 432) is in the folded state, and the second flexible outer structure exhibits the final state when the first flexible outer structure (422, 432) is in the extended state.

2. The ablation catheter device (440, 450, 460) according to claim 1, wherein the at least one internal catheter module (420, 430) is configured as a balloon catheter or has a balloon catheter, and the first flexible external structure (422, 432) is configured as a flexible membrane or has a flexible membrane.

3. The ablation catheter device (440, 450, 460) according to claim 1 or 2, wherein a plurality of electrodes (405_m) are arranged on the outside of the second flexible outer structure.

4. The ablation catheter device (440, 450, 460) according to any one of claims 1 to 3, wherein the second flexible outer structure has a plurality of ribs (404_n) or is formed by a plurality of ribs (404_n).

5. The ablation catheter device (440, 450, 460) according to claim 4, wherein at least one electrode (405_m) is positioned or formed on each of the plurality of ribs (404_n).

6. The ablation catheter device according to any one of claims 1 to 5 (440, 450, 460), wherein the second flexible outer structure has a basket shape.

7. The ablation catheter device (440, 450, 460) according to any one of claims 1 to 6, wherein the inner shafts (406, 416) are arranged within the second shaft (401; 411) to receive one of the at least one inner catheter modules (420, 430).

8. The aforementioned external catheter modules (400, 410) Proximal to the second flexible outer structure, there are electrodes (402, 403), for example, annular electrodes, which are attached to or positioned on the second shaft (401, 411), and / or The ablation catheter device (440, 450, 460) according to any one of claims 1 to 7, wherein the distal end of the second flexible outer structure has electrodes (412, 413), for example, annular electrodes, attached to or positioned on the second shafts (401, 411).

9. A device for ablation of patient tissue, An ablation catheter device (440, 450, 460) according to any one of claims 1 to 8, A signal generator connected to or connectable to the ablation catheter device (440, 450, 460), A control and evaluation unit connected to or connectable to the ablation catheter device (440, 450, 460) and / or the signal generator, A device equipped with the following features.

10. The apparatus according to claim 9, wherein the signal generating apparatus comprises a first signal generator for generating a radio frequency (RF) signal and a second signal generator for generating a signal for pulsed field ablation.

11. The apparatus according to claim 9 or 10, wherein the control and evaluation unit is configured to transmit signals by operating a first signal generator and / or a second signal generator.

12. The apparatus according to claim 11, wherein the control and evaluation unit is configured to operate the first signal generator and / or the second signal generator to send a signal according to the temperature of at least one electrode.

13. The apparatus according to claim 12, wherein the control and evaluation unit is configured to activate the first signal generator and send a signal when the electrode temperature falls below a temperature limit, and to activate the second signal generator and send a signal when the electrode temperature reaches or exceeds the temperature limit.

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